FDA Adverse Event
Summary report: N
SCD RESPONSE-COMPRESSION SYSTEM
MDR report key: 560770
·
Received December 22, 2004
Report
- Report Number
- 1310379-2004-00010
- Date Received
- December 22, 2004
- Date of Event
- October 18, 2004
- Report Date
- December 21, 2004
- Manufacturer
- TYCO HEALTHCARE/KENDAL
- Product Code
- JOW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE IN 2004 THAT CUSTOMER HAD A PROBLEM WITH COMPRESSION SLEEVE. THE CUSTOMER STATED "SEQUENTIAL COMPRESSION DEVICE WAS IN USE ON PT DURING PROCEDURE AND IN RECOVERY. WHEN PT GOT UP DURING DISCHARGE PROCESS, BRUISING WAS NOTED ON THE BACKS OF PT'S LEGS CONSISTENT WITH SCD STOCKING PATTERN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCD RESPONSE-COMPRESSION SYSTEM | 7325 SCD SLEEVE | JOW | TYCO HEALTHCARE/KENDAL | * | E0421804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |